Research Regulatory Coordinator - Remote

Overview

The Research Regulatory Coordinator at Virtua Health is responsible for coordinating regulatory activities related to clinical trials, ensuring compliance with regulatory agencies, and managing documentation for Institutional Review Boards (IRB).

In Short

• Coordinates regulatory activities for phase II - IV clinical trials.
• Prepares and processes regulatory documentation for IRB and other review committees.
• Organizes and maintains regulatory documents for assigned protocols.
• Participates in quality audits and ensures compliance with regulations.
• Communicates with Principal Investigators and study teams about regulatory operations.
• Develops standard operating procedures for regulatory practices.
• Conducts financial tracking for clinical trials.
• Attends study team and sponsor meetings as required.
• Maintains and updates clinical trial information on the Virtua website.
• Orders supplies and performs miscellaneous administrative activities.

Requirements

• Minimum of 3 years of experience in regulatory activities in clinical research.
• Strong organizational and communication skills.
• Ability to function independently.
• Associate degree required; Bachelor’s preferred.
• Mandatory education on Human Subject and Good Clinical Practice.

Benefits

• Medical, dental, and vision insurance.
• Flexible spending accounts.
• 403(b) retirement plan.
• Paid time off and sick leave.
• Short-term and optional long-term disability insurance.
• Tuition assistance.
• Employee assistance program with free counseling sessions.